BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1873041 · Received October 14, 2010

    Report

    Report Number
    3003496686-2010-59271
    Event Type
    Injury
    Date Received
    October 14, 2010
    Report Date
    October 13, 2010
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    PO30050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(6) 2010: THIS CASE INVOLVING A PT OF UNK AGE AND GENDER WHO REPORTEDLY DEVELOPED SYSTEMIC JOINT PAIN WEEKS AFTER POLY-L-LACTIC ACID TREATMENT LACKS SUFFICIENT INFO FOR A COMPLETE MEDICAL ASSESSMENT. ADDITIONAL INFO INCLUDING PT'S AGE, MEDICAL HISTORY AND CONCOMITANT MEDICATIONS, DETAILS OF THE ADVERSE EVENT (INCLUDING WHICH JOINTS WERE INVOLVED, PRESENCE OF ANY ASSOCIATED SIGNS OR SYMPTOMS, I.E. ERYTHEMA, WARMTH, EDEMA, ETC), DETAILS OF POLY-L-LACTIC ACID ADMINISTRATION, PERTINENT DIAGNOSTIC EXAM FINDINGS (INCLUDING CBC WITH DIFFERENTIAL, ANA, RHEUMATOID FACTOR, SEDIMENTATION RATE, THYROID FUNCTION TESTS, CHEMISTRY, LYME TITER, ETC), DETAILS OF CORRECTIVE TREATMENT PROVIDED, FINAL OUTCOME, AS WELL AS THE REPORTER'S CAUSALITY ASSESSMENT IS NEEDED FOR A THOROUGH MEDICAL EVAL OF THIS CASE.

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED FROM A NURSE PRACTITIONER ON (B)(6) 2010: A PT (AGE AND GENDER UNSPECIFIED) RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA) ON AN UNK DATE. THE PT REPORTED THAT SHE HAD SYSTEMIC JOINT PAIN WEEKS AFTER TREATMENT WITH POLY-L-LACTIC ACID. CONCOMITANT MEDICATION AND MEDICAL HISTORY WERE NOT PROVIDED. NO FURTHER RELEVANT INFO PROVIDED. ADDITIONAL INFO FOR INJECTABLE POLY-L-LACTIC ACID (LOT# AND EXP DATE UNK) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE ID (B)(4) DATED (B)(6) 2010, RECEIVED BY (B)(6) ON (B)(6) 2010: BATCH RECORD REVIEWED WAS WITHOUT HINT TO ROOT CAUSE. SINCE NO LOT NUMBER IS AVAILABLE, AN INVESTIGATION HAS BEEN PERFORMED ON THE DOCUMENTATION OF ALL POTENTIALLY INVOLVED MFG BATCHES MARKETED IN THE USA AND THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT IS NOT BATCH RELATED. CONCLUSION: NO FAULTS DETECTABLE. ON (B)(6) 2010, UPON INTERNAL REVIEW, THIS PREVIOUSLY NON-SERIOUS CASE HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATIONS FOR THE EVENT(S) FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH SANOFIAVENTIS U.S. LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CON MEDS = UNK| PREV MEDS = UNK